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New England Compounding Center Meningitis Outbreak: A Compounding Public Health Crisis.

Bolanle A. Olaniran
Department of Communication Studies, Texas Tech University, P. O. Box 43083

Lubbock, Texas 79409-3083, United States of America

Juliann C. Scholl
Department of Communication Studies, Texas Tech University, P. O. Box 43083

Lubbock, Texas 79409-3083, United States of America
E-mail: Juliannscholl@yahoo.com

www.ttu.edu

Abstract

The New England Compounding Center’s (i.e., NECC) meningitis outbreak represents a major public health crisis of 2012
that led to over 40 deaths, along with infection of several hundred individuals. The outbreak necessitates the need for how
such a crisis could be prevented.. The research focuses on assessment of the NECC Meningitis Outbreak using the
Anticipatory Model of Crisis Management (AMCM). Using the AMCM principles, it was found that NECC did not engage
in an adequate vigilant decision making process.

Keywords: Crisis management, Crisis preparedness, Anticipatory model, Meningitis outbreak

1. Introduction
Crises are fairly commonplace in today’s society, either
because we are more aware of their occurrence through
the media, including social media, or because their
impacts are often close to home. Although inevitable in
organizational life, crises are preventable1. The idea that
crises are avertable represents the hallmark of the
anticipatory model of crisis management1-2.
Notwithstanding, organizations rarely do what it takes
to prevent crisis. Some would rather deal with crises
after they occur than commit valuable resources to
prevent crises from happening. This leads to an
assessment and evaluation of the meningitis epidemic
fueled by the New England Compounding Center in late
2012. In essence, the goal of this study is to evaluate
and assess the management of the meningitis crisis

while offering important implications for crisis managers
and practitioners, as well as public health experts.

2. Case overview
New England Compounding Center (NECC) is a
pharmaceutical company embroiled in a crisis of great
proportion. Since September 21, 2012, more than 30
Americans have died of fungal meningitis and almost 300
people have become infected from tainted steroid injections
they received to treat problems with their spines3-5. NECC is
a pharmaceutical company that does compounding, a
practice that involves preparing a medication to suit small
but specific needs that are unmet by larger pharmaceutical
companies. NECC is reported to have shipped close to
18,000 vials of the contaminated steroid to 75 facilities in 23
states, and as a result, many more people stand to be

Journal of Risk Analysis and Crisis Response, Vol. 4, No. 1 (March 2014), 34-42

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Received 21 July 2013

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Olaniran and Scholl

infected with the fungal contaminated product5. The
next section presents a brief overview of the
anticipatory model of crisis management which is used
to analyze the NECC meningitis case.

3. Anticipatory Model of Crisis Management
The anticipatory model of crisis management (AMCM)
posits that while one might not be able to prevent all
crises from occurring, prevention should be a major
priority. The essence of the anticipatory model is that
attempts should be made to put in place programs that
prevent error, disaster, and crisis while also
implementing plans to handle any crises if and when
they do occur. An understanding of the AMCM requires
a clear definition of organizational crisis, which is as an
unpredictable or a major threat that could have a
negative effect on the credibility of the organization, the
industry or its stakeholders 6-8. In keeping with the
impact crises can have on public health, crisis is
characterized as an event that compromises the health
and safety of employees, customers, or and community,
that threatens to destroy public trust in the organization,
thus damaging the company’s reputation 9. The
definition of crisis offered by Pearson et al. reflect the
sense that the prevention of crisis not only safeguards
the public’s health and safety, but also preserves the
trust that the public has for the company to prevent
crises by ensuring their products are safe and that their
business practices and communication with the public
are honest. With regard to public health preservation,
the anticipatory model implies that best practices are
maintained through competent communication within
the organization and with the public.

The notion of anticipation deserves attention here.
Specifically, an anticipatory focus not only thwarts
disasters, but it reduces their magnitude if and when
they do happen10. Furthermore, despite the rare
occurrence of many organizational and health crises, the
brunt is significant when they do occur, which
necessitates an anticipatory approach when planning for
them and preparing for their potential impacts. Finally,
decision makers should possess a deep understanding
and knowledge of conditions, situations, or events that
could signal danger or trigger crisis. This understanding

can be achieved through the specific components of
AMCM, which are outlined subsequently.

Weick11 warns that the very action that enables people
and organizations can also cause destruction. In other words,
crisis is not just something that happens to an organization,
but rather, organizational members and leaders enact
thoughts and engage in actions that can intensify the
conditions that make crises more likely to happen. This idea
pertains to the principles of enactment and expectation
which are germane to the anticipatory model1-2,12-13.
Enactment represents a process whereby a given action is
brought about14. In other words, enactment represents any
activity that puts a plan into motion, embodies an
organizational policy, or reflects a pre-determined response
to an event, such as an anticipated crisis. Based on the
AMCM, enactments are proactive rather than reactive,
meaning that they should not just reflect response to
disasters that have already occurred, but are actions that are
pre-determined.

Weick11 supports extending the notion of enactment to
consequences from such actions. For example, failure to put
in place a crisis plan might hinder eventual crisis
management. With enactment conceived as a retrospective
sense-making process, the model contends that the notion of
“anticipation” (of crisis) in and of itself is an action, given
that it determines the subsequent choices an organization
makes based on available information. Justification of this
argument lies in the fact that decision-makers often find
themselves in situations where they have to anticipate
opportunities, threats, and weaknesses in their environment
and then take appropriate measures to safeguard their
interests. Therefore, the model asserts that decision-makers’
actions or inactions with anticipation would result in
different outcomes.

Expectation, a second AMCM principle, involves
assumptions that people make about certain situations,
environments, technologies, or their combination1-2, 10, 12-13.
For example, expectations about the potential occurrence of
a crisis would determine whether or not a preventive
countermeasure is put in place. Notwithstanding,
assumptions have the potential to bring about a self-
fulfilling prophecy. For example, when organizational
decision-makers assume that a technology is fail safe, they
err and might relax other safety measures such that

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NECC Meningitis Outbreak

additional counter measures are never put in place to
create necessary redundant procedures1-2, 10, 12.

The third element in the model is the idea of
control, which is the degree of power an organization
has over events or crises. A multifaceted term, control is
used to describe how well organizations and decision
makers are in command of crisis situations, as well as
conditions that might lead to crisis. Control, however, is
measured in relative terms, which include the
perceptions of stakeholders and the public10. For
example, if it is discovered that a shipment of medicine
leaving a factory is tainted, control might refer to the
company’s ability to stop the shipment before it hits
pharmacy shelves. The control component intertwines
with expectation and enactment to the extent that
expectations influence enactments (decisions or actions)
and actions exert control over crisis situations.
Acknowledging the notion of control enhances the
ability to prepare and implement effective crisis-
management programs, including positive media
relations, information dissemination, and adaptability to
make changes when necessary.

In sum, crisis prevention requires a thorough
understanding of the complexity of relationships and
their environmental contexts. Nevertheless, enactment,
expectation, and control must be acknowledged to
understand the process1,11. While enactment consists of
specific actions, expectation about an object determines
the type of action taken in the enactment process and
provides organizations the needed control to handle a
crisis. Furthermore, control reflects an organization or
decision-maker’s ability to respond to an expectation
with the appropriate enactment. Taken together these
factors constitute the crisis anticipation process where
managers foresee the occurrence of crisis and work to
eliminate or reduce the degree of the catastrophe. The
relational perspective as it pertains to public health is
useful to facilitate the pre-crisis planning stage of crisis
communication. Beyond gaining and maintaining the
public trust, crisis prevention can be a matter of life and
death for community members.

4. Methods
As is traditionally the norm in crisis management research,
the method employed in this study consists of a case study,
namely the NECC. In an attempt to trace steps, missteps,
and processes culminating in the eventual crisis at NECC,
the researchers utilize and analyze available news materials
from media outlets including blogs, news reports, reports of
interviews from government agencies (e.g., Centers for
Disease Control and Prevention, Federal Bureau of
Investigations, etc.) and stories. Scholars and crisis
communication researchers have employed this particular
method for decades9,15-19. Furthermore, the use of case
studies is considered crucial to crisis management and
theory development20, and case studies often necessitate the
use of any news articles and documents that provide context.
Therefore, the NECC meningitis case materials or
information were viewed to create a timeline of events
surrounding and leading to the eventual crisis (i.e., deaths
and illnesses). Analyzing and creating timelines regarding
news stories provided the researchers an opportunity to go
back in time and assess what went wrong. This analysis also
enabled them to identify windows of opportunity where
NECC could have engaged in crisis planning and/or put in
place an adequate crisis management program.

Moreover, the creation of the timeline provides a
systematic approach that uses assumptions and premises of
the anticipatory model of crisis management (AMCM),
which were used to analyze and evaluate NECC’s crisis
communication and management. Thus, the study assesses
and evaluates available news materials and interviews from
government agencies through the lens of AMCM. From the
analysis, discussions and recommendations were offered.
The next section offers results from the analysis and
evaluation of the NECC meningitis crisis.

5. Analysis and Evaluation of NECC Meningitis Case
The NECC meningitis outbreak offers critical lessons and
links between crisis preparation and issues management.
While crisis management involves three major stages
including pre-crisis, during crisis, and post crisis, issues
management focuses on public policy processes to advance
organizational interests21-22, as well as protect the health and
safety of the public. While crisis management encompasses
all crisis stages, issues management is a proactive method of

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crisis preparedness and prevention, hence focusing on
the pre-crisis stage.

In assessing the meningitis outbreak one needs to
look at policies or rules in effect governing
compounding pharmacies. In so doing, it has been
suggested that one of the policy issues that contribute to
the crisis is the current administration’s recent
tightening of oversight of the manufacturing of generic
versions of sterile injectable drugs5. The tightening was
called for due to legitimate concerns that the Food and
Drug Administration (FDA) had about the reliability of
the manufacturing facilities. However, it is argued that
while the new regulation is aimed at safety issues, it has
also created shortages of drugs. Consequently, the
shortages have forced doctors to seek needed medicines
from compounding pharmacies, which are less regulated
than the generic drug firms5. Notwithstanding this
argument, the recent outbreak of meningitis has
emboldened government agencies in instituting even
tighter laws and regulations. For instance, Federal
health agencies (e.g., Food and Drug Administration,
Centers for Disease Control and Prevention) are focused
on recalling the drugs, and Congress members are called
for investigations and the creation of new laws and
tightened controls over compounding pharmacies5.

An investigation of the role of compounding
pharmacies such as NECC indicates that compounding
medicines never go through formal FDA review.
Compounders frequently distribute these unapproved,
older medicines. However, many of the drugs used by
compounders have been on the market for decades.
These drugs have established proven efficacy with little
to no side effects and have been in existence before the
establishment of the modern FDA review requirements.
These drugs include sterile, injected drugs, such as the
steroid behind the meningitis outbreak5. The point being
made by Gotlieb is that tough oversight comes with or
results in product shortages. However, we beg to differ
because the first responsibility of a government agency
is to preserve and protect the safety of the public. We
are not arguing that government agencies never go
overboard in their regulatory practices. Instead, we
contend that ensuring manufacturing facilities are in
compliance and are operated safely is not too much to

ask any pharmaceutical or medical company, especially a
compounding pharmaceutical company like NECC. After
all, the principle of non malfeasance – which focuses on the
intent to not engage in harm or bring injury to others is at
the core of assessing medical operational guidelines16.

This case study analysis reveals that NECC may have
failed this test of non malfeasance by not adhering to the
basic rule governing compounders, which is never to
circumvent basic pharmacy compounding to full-scale
manufacturing5,23. In other words, a compounding pharmacy
must follow specific prescriptions being compounded rather
than make a large batch and ship the products without
prescription. To this end, Hicks23 reports that Massachusetts
state regulators accused NECC of violating state laws by not
requiring patient prescriptions before shipping products.
Essentially, this practice raised questions about the
pharmacy’s operation. As a result, NECC is said to engage
in drug manufacturing (regulated by FDA) rather than
compounding (not regulated by FDA). As a result, NECC
found itself under investigation and was subject to calls for
further investigations by State Representative Edward
Makey and Governor Deval Patrick, along with U.S.
Attorney Carmenn Ortiz. Furthermore, the entire NECC
entity has been called into question and greater scrutiny due
to the meningitis crisis. The FDA is now investigating the
company’s medication pipelines, including treatments used
during heart surgery, for possible contamination attributed
to a different fungal meningitis in at least two patients23.

6. NECC response to crisis
NECC’s response to the meningitis crisis has been, for the
most part, nonexistent at worst and lackluster at best. As a
whole, their response violates the basic tenets of the
Anticipatory Model of Crisis Management, which is to
anticipate and prepare for crisis in an effort to buffer the
impact of crisis upon occurrence. In the days following the
outbreak of fungal meningitis, NECC was nowhere to be
found. As a matter of fact, it was reported that after the FDA
raided its facilities, the company reacted to the raid through
its attorney and unplugged its website for several days until
October 6, 2012, when it replaced its website with a
statement about the recall23-24. As of October 17, the website
has never been updated. NECC maintains that the
recall came "out of an abundance of caution due to the

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NECC Meningitis Outbreak

potential risk of contamination. While there is no
indication at this time of any contamination in other
NECC products, this recall is being taken as a
precautionary measure."25.

The lack of direct communication from NECC to
the public and other stakeholders conveys a lack of care.
Also, not admitting that the FDA recall was based on
the meningitis outbreak resulting from the contaminated
vials is a pattern of behavior that showed NECC’s
deliberate attempts to be deceptive to the general public
in an effort to circumvent potential lawsuits and
impending prosecution16. The claim that the steroid
recall by the FDA is precautionary is questionable,
especially given that over 300 people have been infected
and more than 30 have died23. More importantly, the
resulting behavior by the NECC is less than vigilant; it
neither conforms to good public relations practices nor
conveys good corporate citizenry.

With regard to principles of the anticipatory model,
NECC have failed to analyze potential consequences of
a failure to accept responsibility, and they pursued a
silence strategy. A vigilant and prior assessment of such
a strategy would have suggested that it is only a matter
of time before affected members of the public would
start filing lawsuits, as is currently the case3,16,23. It
would have been more prudent for NECC to be out in
the public helping affected people and conveying the
impression that the company is doing everything in its
power to make things right rather than keeping silent.
Furthermore, silence and denial usually embolden other
stakeholders, and especially whistleblowers, to come
forward either to get their media time or to vilify the
company. At the same time, organizations that remain
out of sight in times of crisis are perceived to be guilty
and attract more lawsuits and closer media scrutiny as
did Exxon, Shell, and BP16,19,23. It also appears that
NECC did very little to help itself. A report indicated
that when investigators raided its facilities, it was
unimaginable what they found in what was supposed to
be a sterile facility25. For instance, mats at sterile
entrances used to wipe dirt, dust, and other possible
contaminants from shoes were dirty and soiled with
assorted debris, according to Dr. Madeline Biondolillo
of the Massachusetts Department of Public Health25.

Perhaps the most damaging evidence is meningitis-linked
fungus (i.e., visible black fungus) found in unopened
vials that were shipped to several states25-27, which by any
standard is unjustifiable and constitutes irresponsible
behavior on the part of NECC. Clarke and McLaughlin4
report that the problem of unsanitary and questionable
practices at NECC dates back to 1999 with the most recent
reprimand occurring in 2006 when NECC was evaluated by
an outside firm that found inadequate documentation and
process controls involving sterilization at NECC. It stands
to reason that a company that underwent a severe reprimand
in 2006 would be more vigilant and take necessary and
periodic measures to make sure that it never repeated the
same mistake that could ultimately force it out of business.

Unfortunately, this was not the path NECC chose.
Sheldon Bradshaw (a former FDA Chief Counsel), who
signed the enforcement letter in 2006 warning NECC about
potential microbial contamination, puts it succinctly when
interviewed on CBS’s 60 Minutes: "Well, it's clear the
company [NECC] made a conscious effort to disregard that
warning letter because only a few years later they were
engaged in the very behavior the FDA warned them
about"28. During that same broadcast, a former NECC
employee indicated that he witnessed technicians handling
drug vials without hair nets or gloves. Another former
employee indicted the owners by indicating that the
company's owners discussed as far back as 2009 as to
whether NECC had crossed the line from compounding,
which involves mixing approved drugs for individual
prescriptions which is allowed to manufacturing, which
would require more oversight. Sheldon Bradshaw suggested
that NECC is among other large drug manufacturers who
operate under the pretense of traditional pharmacy
compounding but are clearly violating the law, and that they
do so simply because they think they can get away with it28
(Doane, 2012).

The above illustrates the AMCM principle of
expectation and enactment about crisis facilitate or hinder
crisis preparedness and response1-2,12. For instance, the fact
that NECC management considered the possibility of
crossing the line between small-scale compounding to large-
scale manufacturing suggests they were aware of the
possibility of breaking the law. Notwithstanding, there is
something to be said about the fact that it is possible that

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some of the employees in the 60 Minutes interview may
be disgruntled, but the public’s perception in times of
crisis is more likely to be anti-establishment or anti-
organization than favorable. At the same time, the
impression that NECC management continues to
operate its business as usual and consequently, it has
managed to get away with some violations up to that
point, might continue to operate with the expectation of
going undetected. Otherwise, NECC would have taken
the necessary steps to go through FDA requirements for
manufacturing or take corrective measures. This would
appear as a faulty assumption on the part of NECC and
its management. As is the case with any faulty
assumption, it often results in fallible enactment or
actions whose consequences can be dire2,11,13,16. From
another standpoint, the AMCM contends that
assumptions and expectations presented by the model
constitute vigilant decision making13,29 only when
decision makers like NECC are able to efficiently and
effectively analyze and evaluate outcomes1.
Furthermore, some scholars have discussed the fact that
most crises are preceded by clear warning signals but
often frequently ignored22,30-31. Unfortunately, NECC
fell short as did other organizations, given that it did not
appropriately anticipate any negative consequences
from blurring the line between pharmaceutical
compounding and manufacturing. Similarly, failure to
engage in appropriate precautionary measures
undermines the degree of control that the organization
has over the crisis and its management1-2,10,13.

In terms of AMCM’s principle of control, NECC
engaged in some missteps that made it lose control in its
crisis management effort. For instance, its decision not
to take seriously the FDA warnings in 2004 and 2006
creates the perception that the company does not care28.
The failure to engage or enact a voluntary recall of its
steroidal injection as soon as the first victim died, and
the decision to wait for directions from the FDA, and
then suggesting that the FDA’s recall is only a
precaution does not bode well for the company12,16,23.
The failure to engage the public and communicate in a
manner that demonstrates care to victims and
stakeholders did not represent a competent control of
the crisis16,19. Also, the fact that one of the co-owners of

NECC (i.e., Conigliaro) operates a company that recycles
foam insulation that is run from the same complex as the
NECC28 violates safety requirements that a sterile
pharmaceutical operation demands.

7. Implications
Crisis preparedness is important and essential for any
organization, particularly when public health is at stake. An
organization need not wait for crisis to occur before
developing a crisis management plan. It appears that NECC,
despite several warning signs, considered itself invulnerable
to crisis. Vigilant anticipation requires more than just
organizing far in advance and preparing speeches to
minimize crisis effects on an organization32. Successful
anticipation and vigilance involves risk assessment and
critical evaluation of potential vulnerabilities from different
causes of actions and inactions. Effective and proactive
communication is important to maintain with the affected
publics and stakeholders in times of crisis. Failure to select
appropriate spokespersons other than lawyers can hinder
any crisis management effort. Lawyers or legal counsel are
paid to deal with liability, but adequate crisis management
goes beyond liability avoidance; it must convey sincerity,
adherence to the principle of non malfeasance, and genuine
apology. The moment of crisis is not the time to put
financial considerations ahead of public safety16. From a
pre-crisis standpoint, it is important that organizations
identify potential source(s) of crisis and develop a plan of
action to prevent them and consequently enact the plan
when a crisis occurs.
In the case of NECC, contamination prevention is one
such area of crisis management, and efforts or programs
ought to be in place to put sanitation as a top priority and
not wait until regulators identify problems. Furthermore,
operating in tandem within the boundary of regulations is
prudent. If the management can catch itself or speculate that
there is the potential of violating the law, chances are it is.
Therefore, the management must take appropriate measures
to ensure that the company is in compliance. Doing the right
thing might be difficult at first, but in the long run it would
save the company from a bigger headache. Thus, it is
imperative that organizations should make every effort to do
things right the first time.

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NECC Meningitis Outbreak

The NECC meningitis outbreak crisis underscores
the importance of prevention and crisis management to
safeguard and protect the community from a public
health standpoint. The protection can be done from an
issues management perspective, which emphasizes the
need for increased regulations and the demand for
stricter compliance with current regulations to protect
the public and health consumers. The public needs to
demand better from pharmaceutical companies and
retail pharmacies regarding how their medications, and
in particular compounding medicine, might affect them.
Lack of knowledge and information from this
standpoint is likely to result in more episodes like the
meningitis outbreak that will further put the public and
their health at risk. Moreover, the risk might not
necessarily be limited to compounded drugs but other
manufactured medicines, as illustrated in the Johnson
and Johnson phantom recall case16.

In essence, the NECC crisis is only symptomatic of
what could potentially unfold in the public health arena.
The overall goal of public health is to educate the public
on matters of health and safety whenever necessary,
monitor industrial health standards, and prevent or at
least control the outbreak of illness and infection33.
NECC has a responsibility to the public to process and
disseminate products that are safe and effective, and to
take the best measures possible not to hamper the health
of the population segment that needs their drugs.
Moreover, NECC has the obligation to be transparent
about product flaws that may have unfortunately made
their way to the market. Given these responsibilities and
obligations, this study contends that NECC failed in its
part to promote and safeguard public health. Hence
individuals, government agencies, and communities at
large would be better served in identifying such
potential sources of healthcare crises and develop
appropriate steps to safeguard against them as specified
by the tenets of AMCM.

Finally, this case brings to the forefront that issues
management and crisis management often go hand in
hand. Issues management, in essence, represents a
strategic approach to crisis management, and in terms of
AMCM and crisis prevention, crisis is indicative of a
distinct pattern of unfolding occurrences, and the

patterns are identifiable even prior to a triggering event2,22.
For instance, in the case of NECC, there are the warnings
based on FDA regulations and guidelines for pharmaceutical
compounders versus manufacturers, and then there are
previous violations and compliance notifications prior to the
actual cases of fungal meningitis infection. These
circumstances could have prompted NECC to make some
pivotal decisions to prevent a full-scale meningitis
outbreak16. How organizations choose to respond to a crisis
could make or break the success of its crisis management
plan because publics are more likely to remember not only
that the crisis occurred, but more importantly, how an
organization responded to the crisis.

8. Limitations
This present study utilizes a case study methodological
approach. As is with any case study approach,
generalization is problematic and should be done with
caution. More empirical studies should be conducted as to
the specific causes of miscommunication with the public
and the lacking precautionary measures. Nevertheless, the
attempt to understand what happened with the NECC,
regardless of methodology, still offers crisis managers a
general glimpse of what to do and what not to in crisis
planning and management. As discussed in the paper, the
idea of anticipation of crisis potentials and possibilities is
something from which any organization, regardless of size,
can benefit. Furthermore, anticipation by itself is not
sufficient until organizational leaders develop a plan of
actions to prevent or at least minimize catastrophe should
crisis ensue. Finally, waiting for crisis to occur before
engaging a crisis plan is reactionary rather than proactive.
These conclusions, regardless of idiosyncrasies of
organizations or environments, are valuable to any crisis
prevention and management.

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