Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Vapor Technology Association v. Baker

Superior Court of Massachusetts, Suffolk

October 21, 2019

VAPOR TECHNOLOGY ASSOCIATION, et al.
v.
Charlie BAKER, In His Official Capacity as Governor of the Commonwealth of Massachusetts, et al.

          MEMORANDUM OF DECISION AND ORDER ON PLAINTIFFS’ MOTION FOR PRELIMINARY INJUNCTION

          Douglas H. Wilkins, Associate Justice, Superior Court

          On 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 ("Commissioner") (collectively, "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 Governor’s 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 "Plaintiff’s 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

          Solely for purposes of the Motion, and without in any way affecting the parties’ 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:

          The Vaping Industry

         Vaping devices (also known as "e-cigarettes") are handheld electronic devices that aerosolize a liquid mixture containing nicotine, cannabis-derived products or other ingredients. The Governor’s 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 since mid-2017.

          The 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, including Devine’s.

          The Order

          The Order’s 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 Commonwealth.

          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."

          The Order also provides for enforcement by fines and other means:

Pursuant to the authority granted by G.L.c. 17, § 2A, this Order may be enforced in the manner of a regulation adopted pursuant to G.L.c. 111, § 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, § 31; provided that violations shall be calculated on a per item and per transaction basis and may be punished cumulatively. [Emphasis added].

          On 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 Governor’s September 24, 2019 Declaration of a Public Health Emergency."

          The Science

         The 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 this disease.

         The 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 (https://www.cdc.gov/tobacco/basic_information/ecigarettes/severe-lung-disease.html) (last visited October 18, 2019):

          What We Know

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 vaping, products.
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.

          What We Don’t 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.

          What CDC Recommends

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.

          Latest Outbreak Information

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 ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.