VAPOR TECHNOLOGY ASSOCIATION, et al.
Charlie BAKER, In His Official Capacity as Governor of the Commonwealth of Massachusetts, et al.
MEMORANDUM OF DECISION AND ORDER ON PLAINTIFFSâ
MOTION FOR PRELIMINARY INJUNCTION
Douglas H. Wilkins, Associate Justice, Superior Court
October 4, 2019, the plaintiffs Vapor Technology Association
("Association"), Ian Devine ("Devine")
and Devine Enterprise, Inc. ("Company")
(collectively, "plaintiffs") filed their complaint
against defendants, Charlie Baker, in his official capacity
as Governor of the Commonwealth of Massachusetts
("Governor"), and Monica Bharel, M.D., in her
official capacity as Department of Public Health Commissioner
"defendants"). They challenge an emergency order
prohibiting the sale or display of all vaping products to
consumers until January 25, 2020. See the "Order of the
Commissioner of Public Health Pursuant to the Governorâs
September 24, 2019 Declaration of a Public Health
Emergency" ("Order"). The Complaint alleges
that the Order reflects executive over-reach, which violates
state constitutional separation-of-powers principles, and is
arbitrary and capricious. It seeks injunctive relief to
invalidate the Order.
Accompanying the complaint was the "Plaintiffâs Motion
for a Preliminary Injunction" ("Motion"). The
court heard argument on October 8, 2019 and took evidence
from three live witnesses on October 9 and 18, 2019. The
parties supplemented their original filings with written
filings on October 16 (defendants) and October 17
(plaintiffs). After hearing, the Motion is ALLOWED IN PART
AND DENIED IN PART.
PRELIMINARY FACTUAL FINDINGS
for purposes of the Motion, and without in any way affecting
the partiesâ rights to litigate the factual issues later in
this case, the court finds, on the limited record available
at the preliminary injunction stage, that the parties are
likely to prove following facts:
devices (also known as "e-cigarettes") are handheld
electronic devices that aerosolize a liquid mixture
containing nicotine, cannabis-derived products or other
ingredients. The Governorâs Declaration of Emergency dated
September 24, 2019 ("Declaration of Emergency")
lists a number of components that vaping products may
contain, including THC, flavorings, propylene glycol,
vegetable glycerin and, sometimes, toxic chemicals or metal
particles. A user inhales the aerosolized vapor into the
lungs. Unlike traditional combustible cigarettes, vaping
devices do not produce flame or ash. Some professionals and
officials view e-cigarettes as a safer alternative to smoking
combustible cigarettes. Others disagree.
Nicotine e-liquids were subjected to regulation by the U.S.
Food and Drug Administration ("FDA") as of August
8, 2016 and have been on the market in their current form
vaping-products industry employs approximately 166,000 people
nationwide, including approximately 2,530 in Massachusetts.
In Massachusetts, employers include 8 nicotine-vapor products
manufacturers, 1 nicotine-liquid-mixture manufacturer and 221
retail vape shops. Massachusetts vapor-products companies and
sellers and their employees contribute nearly $19 million in
state taxes. Sales taxes on vaping products in Massachusetts
generate about $10.7 million annually. The plaintiffs assert
that the Order will force a permanent shut down of stores,
Orderâs operative paragraph reads:
The sale or display of all vaping products to consumers in
retail establishments, online and through any other means,
including all non-flavored and flavored vaping products,
including mint and menthol, including tetrahydrocannabinol
(THC) and any other cannabinoid, is prohibited in the
Order then defines the term "vaping products" and
exempts "any product that has been approved by the
federal Food and Drug Administration either as a tobacco use
cessation product or for other medical purposes and which is
being marketed and sold or prescribed solely for the approved
purpose." The Order "takes effect immediately and
shall remain in effect, unless extended with the approval of
the Governor and the Public Health Council, through January
25, 2020, or until the declared public health emergency is
terminated, or the Order is otherwise rescinded by me,
whichever happens first."
Order also provides for enforcement by fines and other means:
Pursuant to the authority granted by G.L.c. 17, Â§ 2A, this
Order may be enforced in the manner of a regulation adopted
pursuant to G.L.c. 111, Â§ 31, and by injunction through
proceedings initiated in the Superior Court. A person or
entity found in violation of this Order may also be subject
to the maximum fine provided in G.L.c. 111, Â§ 31;
provided that violations shall be calculated on a per item
and per transaction basis and may be punished cumulatively.
October 4, 2019, apparently in response to federal
litigation, the Commissioner made certain clarifications or
changes not relevant here, in an "Implementation Order,
Order of the Commissioner of Public Health Pursuant to the
Governorâs September 24, 2019 Declaration of a Public Health
parties appear to agree on certain points. Since August 2019,
a serious, multistate outbreak of vaping-associated pulmonary
disease has come to the attention of the medical and public
health professions, as well as regulators. The parties to
this case agree that vaping THC products and products
obtained on the black market cause such disease. They
disagree whether nicotine vaping products also have caused
most authoritative and objective discussion of the lung
injury outbreak caused by vaping appears in the publications
of the Centers for Disease Control and Prevention
("CDC") and the FDA. As of October 17, 2019, the
CDC has published the following information, among other
things, on its website
(last visited October 18, 2019):
As of October 15, 2019, 1,479* lung injury cases associated
with the use of e-cigarette, or vaping, products have been
reported to CDC from 49 states (all except Alaska), the
District of Columbia, and 1 U.S. territory.
Thirty-three deaths have been confirmed in 24 states.
All patients have reported a history of using e-cigarette, or
We do know that THC is present in most of the samples
tested by FDA to date, and most patients report a history of
using THC-containing products. The latest national and state
findings suggest products containing THC, particularly those
obtained off the street or from other informal sources (e.g.
friends, family members, illicit dealers), are linked to most
of the cases and play a major role in the outbreak. As such,
we recommend that you should not use e-cigarette, or vaping,
products that contain THC.
Since the specific causes or causes of lung injury are not
yet known, the only way to assure that you are not at risk
while the investigation continues is to consider refraining
from use of all e-cigarette, or vaping, products. The use of
e-cigarettes, or vaping, products is unsafe for all ages,
including youth and young adults. Nicotine is highly
addictive and can harm adolescent brain development, which
continues into the early to mid-20s.
We Donât Know
At this time, FDA and CDC have not identified the cause or
causes of the lung injuries in these cases, and the only
commonality among all cases is that patients report the use
of e-cigarette, or vaping, products.
No one compound or ingredient has emerged as the cause of
these illnesses to date; and it may be that there is more
than one cause of this outbreak. Many different substances
and product sources are still under investigation.
The specific chemical exposure(s) causing lung
injuries associated with e-cigarette product use, or
vaping, remains unknown at this time.
CDC recommends that people should not :
Use e-cigarette, or vaping, products that contain THC.
Buy any type of e-cigarette, or vaping, products,
particularly those containing THC, off the street.
Modify or add any substances to e-cigarette, or vaping,
products that are not intended by the manufacturer, including
products purchased through retail establishments.
At present, CDC continues to recommend that people
consider refraining from using e-cigarette, or vaping,
products that contain nicotine.
If you are an adult using e-cigarette, or vaping, products to
quit cigarette smoking, do not return to smoking cigarettes.
Use evidence-based treatments, including healthcare provider
counseling and FDA approved medications. [icon omitted].
If you have recently used an e-cigarette or vaping product,
see a healthcare provider immediately if you develop symptoms
like those reported in this outbreak.
Irrespective of the ongoing investigation:
E-cigarette, or vaping, products should never be used by
youths, young adults, or women who are pregnant.
Adults who do not currently use tobacco products should not
start using e-cigarette, or vaping, products.
THC use has been associated with a wide range of health
effects, particularly with prolonged heavy use. The best way
to avoid potentially harmful effects is to not use THC,
including through e-cigarette, or vaping, products. Persons
with marijuana use disorder should seek evidence-based
treatment by a health care provider.
There is no safe tobacco product. All tobacco products,
including e-cigarettes, carry a risk.
CDC will continue to update guidance, as appropriate, as new
data emerges from this complex outbreak.
As of October 15, 2019, 1,479* lung injury cases associated
with e-cigarette use, or vaping, have been reported to CDC
from the District of Columbia, 1 U.S. territory (USVI) and
all 49 states (all except Alaska).
Thirty-three deaths have been confirmed in 24 states:
Alabama, California (3), Connecticut, Delaware, Florida,
Georgia (2), Illinois, Indiana (3), Kansas (2),
Massachusetts, Michigan, Minnesota (3), Mississippi,
Missouri, Montana, Nebraska, New Jersey, New York, Oregon
(2), Pennsylvania, Tennessee, Texas, Utah and Virginia. More
deaths are under investigation.
The median age of deceased patients was 44 years and ranged
from 17 to 75 years.
Among 1,358 patients with data on age and sex:
70% of patients are male.
The median age of patients is 23 years and ages range from 13
to 75 years.
79% of patients are under 35 ...