SE, NJoy vs FDA -- court dockets / updates

[Sun Vaporer]

Today there was no movement on the Docket Sheet. Judge Leon did not act on ASH"s request to file a Brief as Friend of the Court or SE's opposition thereunto. I would hope ASH's Motion is struck as it will only further delay a decision.


Sun

 

[Sun Vaporer]

Today a group calling themselfs the ALLIANCE OF ELECTRONIC SMOKERS and descriping themselfs as a group of AD Hoc (case by case) group of e-cig smokers, filed leave with the Court to file an amicus curiae brief with a supporting Motion and Memorandum.

This group does not list its address or affiliation or structure. It was filed by Counsel in Washington DC. I will get the thrust of their Motion up as soon as I read it.



There was no action taken on SE's Opposition to ASH's filing or the main action's Preliminary Injunction.

I will post again shortly

Sun

 

[Sun Vaporer]

Today Judge Leon took no actions on any of the pending matters before him.

What is outstanding for him to still rule on are the following:

(1) SE's Motion in Opposition to ASH's Amicus Brief;

(2) Alliance of Electronic Smokers' Request to File Leave of it's Amicus Brief

(3) SE and njoy's Motion for a Prelinary Injunction.

While ASH's Brief adds no new or viable alternatives or theories to the case, it should rightfully be struck. On the other hand, our Alliance's Brief sheds viable light and new legal theory's that are helpful to the Court and should be allowed---as that is the standard of an Amicus Brief.

I thank all of our Members that participated in getting this Brief up and running and to Counsel for writing and submitting it Pro Bono.

As this was a short Holiday week, we saw no ruilings from the Judge.

Next week should bring much awaited news.


Sun

 

[Sun Vaporer]

[FONT=TimesNewRomanPSMT,Bold]Today the FDA filed a reply to Alliances Amicus Curiae Brief, and instead of opposing it, took the opportuinty of this filing presented to once again lay out their argument to the Court. I find this filing by the FDA to be of much more substance than their pervious filings and also written by different Counsel. This Brief by far, is the FDA’s most damaging one to date:

They argued:
[/FONT]　
　
1. Alliance misleadingly implies that the Supreme Court in [FONT=TimesNewRomanPSMT,Italic]FDA v. Brown & Williamson tobacco Corp., [/FONT]529 U.S. 120 (2000), determined that FDA lacks jurisdiction over tobacco products unless a manufacturer makes claims of therapeutic benefit. Alliance Br. at 3. In fact,
the Supreme Court expressly stated that it was [FONT=TimesNewRomanPSMT,Italic]not [/FONT]deciding that question:

Alliance takes issue with the FDA’s reading of "intended," arguing that it is a term of art that refers exclusively to claims made by the manufacturer or vendor about the product. See Brief for Respondent Brown & Williamson Tobacco Corp. 6. That is, a product is not a drug or device under the FDCA unless the manufacturer or vendor makes some express claim concerning the product’s therapeutic benefits. See [FONT=TimesNewRomanPSMT,Italic]id.[/FONT]The FDA argued that they "not resolve this question, however, because assuming, arguendo, that a product can be "intended to affect the structure or any function of the body" absent claims of therapeutic or medical benefit, the FDA’s claim to jurisdiction contravenes the clear intent of Congress"..............................


The FDA went on to argue that "Alliance’s entire argument that FDA drug jurisdiction is limited to products for which the "manufacturer makes [FONT=TimesNewRomanPSMT,Italic]express claims of therapeutic benefit[/FONT]" is groundless. ....... Under the statute and FDA regulations (21 C.F.R. §§ 201.128, § 801.4), and as borne out in FDA regulatory practice and upheld by the courts, the intended use of a drug or device – whether to affect the structure or any function of the body or for use in the diagnosis, cure, mitigation, treatment, orprevention of disease – "may be derived or [FONT=TimesNewRomanPSMT,Italic]inferred [/FONT]from labeling, promotional material, advertising, or [FONT=TimesNewRomanPSMT,Italic]any other relevant source[/FONT]." [FONT=TimesNewRomanPSMT,Italic] In addition to express claims of therapeutic benefit, this evidence has included non-therapeutic claims, implied claims, product[/FONT] formulation, directions for use, circumstances of sale, and the like. [FONT=TimesNewRomanPSMT,Italic]("The various items of evidence strongly suggest that appellants were distributing ‘drugs’ within the meaning of [the FDCA]" – one such item being the "commercial name" of the product); [/FONT][FONT=TimesNewRomanPSMT,Italic].................................　

[/FONT]The FDA stated that Alliance, SE and NJOY all ignores the exclusion of drugs, devices, and combination products from the definition of "tobacco products" in Sec. 101(a) of the FSPTCA. [FONT=TimesNewRomanPSMT,Italic]See [/FONT]U.[/LEFT]
[FONT=TimesNewRomanPSMT,Bold]

The FDA advanced a very strightforward, concise, clear cut Brief that Judge Leon will be taking a hard look at.

Sun​

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[Sun Vaporer]

Today, SE filed a very strong Status Report with the Court spelling out recent events and the fact that should their Motion not be granted, it will but SE out of business do to the FDA’s alleged overreaching.

So now we have the following motions under advisement:

(1) SE’s Motion in Opposition to ASH’s grant for leave to file their Amicus Brief;
(2) Alliance’s Motion for Leave to file an Amicus’s Brief;
(3) SE’s Leave to File a Status Report;
(4) SE’ and NJOY’s Motion for a Preliminary Injunction.

Remember that SE asked for this relief all the way back on April as a TRO that the Judge merged into the Prliminary Injuction request and SE has yet to see a ruling on their Motion. Some of the delay was due in fact to waiting to see if the new Legislation would pass and then the Court requesting a further hearing to see how/if that new legislation affected the case. Also more filings delayed a ruling.

There should be no reason to deley any further at this point. What SE is saying to the Court, is thier Motion will be moot if the Court does not act for the simple reason that SE will be out of business.

It does not get any more exigent then that.


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[Sun Vaporer]

Today the FDA filed an Emergency Motion to Stay the Preliminary Injuction granted to SE and NJOY until Febuary 1, 2010 pending their decision to Appeal.


Sun

 

[Sun Vaporer]

Entered today, but ruled on Saturday, Judge Leon denied the FDA's Emergency Motion for a Stay of the Preliminary Injunction to Allow the Solicitor General to Determine Whether to Appeal and to Seek a Stay Pending Appeal.

This was in fact expected and more of a procedural move as the FDA needed a ruling on a Stay at the lower level before asking for one in the Appeals Court.


So the FDA was by no means counting on this motion to succeed, rather it was a necessary filing in the furtherance of advancing their case.


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[Sun Vaporer]

[FONT=TimesNewRomanPSMT,Bold]

Today the FDA liled a Emergency Motion for Reconsideration or to stay pending appeal


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[Sun Vaporer]

Today, the FDA's Appeal was Docketed in the United States Court of Appeals for District of Columbia Circuit and GRANTED the FDA's Motion to Stay Judge Leon's Ruling Pending Appeal.

So we have an Aministrative Stay in place, which in no way relflects the merits of the case, but rather so the Appeals Court can review the record and hear from the parties. The Appeals Court will rule on the substanitive merit of the Stay after that

Sun

 

[Sun Vaporer]

Docketed today in the Appeals Court was both SE's and NJOY's Disclosure Statements to the Court. Again normal procedural filings in an Appeal.


Sun

 

[Sun Vaporer]

Today, as reqested by the Appeals Court Panel, SE and NJOY filed their
Joint Opposition to the Fda's Emergency Motion for Stay Pending Appeal


All in all, it was a very good Motion. The FDA has until Monday to file their Motion advancing why they should be granted a Stay.


Sun

 

[Sun Vaporer]

Today, as mandated by the Appeal's Court, the FDA submitted it's Reply for a Stay as follows:


REPLY IN SUPPORT OF MOTION FOR STAY PENDING APPEAL

The FDA argues that the ruling issued by Judge Leon was in fact an end all ruling that E-cigs are tobacco products. The FDA contends that they are drug deliver systems and challanges their intented use.


Sun

 

[Sun Vaporer]

Today the Docket Sheet showed that the FDA Supplemented it's Reply Brief to include 3 sets of Exhibits:
(1) A Regulatory Letter from 1987 similar to what Jerry here:

Regulatory Letter. Favor Smokeless Cigarettes Regular. Favor Smokeless Cigarette Menthol. Favor Smokeless Cigarettes Lights. Favor Smoke-Free Cigarettes Regular. Favor Smoke-Free Cigarettes Menthol. Favor Smoke-Free Cigarettes Lights

(2) The Website and brochures of Smoking Everywhere;

(3) A Letter which attacking Nicogel:

The FDA appears to be sticking to its stance all the way.


Sun

 

[Sun Vaporer]

Today the Docket sheet, although showing no new entires, reveled an error as follows:

John F. Banzhaf, Executive Director of Action on Smoking and Health (ASH) as a Plaintiff - Appellee along with SE and NJOY. This is in error that the Court will correct---a little humorus though to say the least having Mr. Banzhaf in as a Plaintiff in this case.



Sun

 

[Sun Vaporer]

A major blow on the Docket Sheet today as the Appeals Court ruled that the FDA met it its burden of "a high likelyhood of sucess" on the merits of the Appeal ot issue a full Stay pending a ruling on the Appeal.

As stated:

Smoking Everywhere, Inc., et al.,
Appellees
v.
Food & Drug Administration, et al.,
Appellants​

[FONT=Arial,Bold]

BEFORE:​

[/FONT]Ginsburg, Griffith, and Kavanaugh, Circuit Judges​

[FONT=Arial,Bold]

O R D E R​

[/FONT]

Upon consideration of the emergency motion for stay pending appeal, the joint
opposition thereto, and the reply; and the court's administrative stay issued February 2, 2010, it is​

[FONT=Arial,Bold]ORDERED [/FONT]that the administrative stay be dissolved.

It is [FONT=Arial,Bold]FURTHER ORDERED [/FONT]that the motion for stay be granted. Appellants have
satisfied the stringent standards required for a stay pending appeal. See Washington
Metropolitan Area Transit Commission v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C.
Cir. 1977); D.C. Circuit Handbook of Practice and Internal Procedures 32-33 (2009).
It is​

[FONT=Arial,Bold]

FURTHER ORDERED​

[/FONT], on the court's own motion, that consideration of this
appeal be expedited. The Clerk is directed to enter a briefing schedule and to calendar
this case for oral argument on the first appropriate date in September 2010.​

[FONT=Arial,Bold]

Per Curiam
FOR THE COURT.

This means the Appeals Court is leaning with the FDA and is the worst news we could have gotten at this point. But the case is far from over.

Sun​

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[Sun Vaporer]

Today the "Legal Foundation" Filed its intent to file an Amicus Curiae Brief for SE:

[FONT=TimesNewRoman,Bold][FONT=TimesNewRoman,Bold]

NOTICE OF WASHINGTON LEGAL FOUNDATION OF INTENT TO FILE ​

[/FONT]​

[/FONT]AMICUS CURIAE BRIEF IN SUPPORT OF PLAINTIFFS/APPELLEES

Pursuant to Fed.R.Civ.P. 29 and Circuit Rule 29(b), the Washington Legal Foundation (WLF) hereby notifies the Court if its intent to file an amicus curiae brief in this case in support of Plaintiffs/Appellees. In support of this notification, WLF states as follows:

1. WLF is a public interest law and policy center that devotes a substantial portion of its resources to defending and promoting free enterprise, individual rights, and a limited and accountable government.

2. WLF hereby represents that all parties to these proceedings have
consented to the filing of WLF’s proposed amicus curiae brief.

3. This appeal was docketed by the clerk on February 1, 2010. This
notice is timely filed under Circuit Rule 29(b), which requires that notice ofintent to file a consented-to amicus curiae brief must be filed within 60 days of the date of docketing.

4. Amicus intends to file a brief in this case that will urge the Court to
limit the definition of the “drugs” or “devices” that are subject to regulation by the Food and Drug Administration, and that will explain the anomalous results of an inappropriately expansive approach.

5. WLF at this time is unaware of any other individual or organization that
plans to file an amicus curiae brief in support of Plaintiffs/Appellees. Should it become aware of any other potential amicus filers, it will consult with them and, to the extent practicable, will endeavor to join in a single brief.


Good Group----------Sun​

 

[Sun Vaporer]

Today, all the "big guns" filed a Motion for Leave of the Court to file an Amicus Brief. With these groups, you can rest assured that their Motion to file will be granted. Looks more like a "title wave" then a Motion coming right at us.

​

Sun​

MOTION OF THE AMERICAN ACADEMY OF PEDIATRICS, AMERICAN
CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART
ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG
ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, CAMPAIGN FOR
TOBACCO-FREE KIDS, AND PUBLIC CITIZEN FOR LEAVE TO PARTICIPATE AS
AMICI CURIAE SUPPORTING THE APPELLANTS, FDA ​

...........The American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Legacy Foundation, the American Lung Association, the American Medical Association, the Campaignfor Tobacco-Free Kids, and Public Citizen respectfully move this Court for leave to participate as amici curiae in the above-captioned case.The proposed amici are all national organizations committed to preserving the public health and have each been at the forefront of efforts to curb the use of cigarette and other nicotine-delivery products in the United States. As such, the proposed amici have a strong interest in the question of whether FDA may regulate the electronic nicotine-deliveryproducts at issue in this case...........​

(1) The American Academy of Pediatrics----60,000 primary care physicians,
pediatric medical subspecialists, and pediatric surgical specialists. AAP has engaged in broad and continuous efforts to prevent harm to the health of children and adolescents caused by the use of tobacco products and exposure to second-hand tobacco smoke......................

(2) The American Cancer Society ("ACS") has more than three million volunteers
nationwide, including 50,000 physicians. , helping to educate government officials on cancer as a public policy issue. ACS CAN has almost half a million grassroots advocates............​

(3) The American Heart Association (“AHA”) with 22.5 million volunteers and supporters in nearly 2,000 community. lives. AHA has long been active before Congress and regulatory agencies on tobacco related issues............................


(4) American Legacy Foundation develops programs that address the health effects of tobacco use.........................


(5) The American Lung Association (“ALA”) has nearly 400,000 volunteers. Since cigarette smoking is a major cause of chronic obstructive lung disease, ALA has long been active in research, education and public policy advocacy on the adverse health effects of tobacco products. ALA has advocated for the regulation of these products for more than two decades.......................


(6) The American Medical Association (“AMA”), an association of approximately 240,000 physicians, residents, and medical
students, The AMA has long had an interest in the regulation of tobacco products and the tobacco industry. As an institution, it has developed expertise in the pharmacology of nicotine, the toxic effects of cigarette smoke, and the societal implications of tobacco usage.................

(7). The Campaign for Tobacco-Free Kids works to raise awareness that cigarette
smoking is a public health hazard by advocating public policies to limit the marketing and sales of tobacco to children............................

(8) Public Citizen , with more than 200,000 members and subscribers nationwide. Public Citizen has long been active before Congress, regulatory agencies, and the courts in matters relating to public health in general and regulation by the Food and Drug Administration (FDA) in particular. Concerned about the severe health risk posed by tobacco products. Public Citizen has long advocated for increased regulation of these products and of the promotional efforts of the tobacco industry...........................................
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[Sun Vaporer]

Today the Motion filed by AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LEGACY FOUNDATION, AMERICAN LUNG ASSOCIATION, AMERICAN MEDICAL ASSOCIATION, CAMPAIGN FOR TOBACCO-FREE KIDS, AND PUBLIC CITIZEN to participate as amicus curiae was Amended.

In part it states:

"​

​

​

​

Moreover, lest there be a concern that the filing of the proposed
amici’s brief and the appellants brief on the same day might result in repetition of argument and redundancy, counsel for appellants has agreed to share a draft of the appellants’ brief with the proposed amici a week before it is due, so that the proposed amici may tailor their brief to avoid duplication and repetition of the appellants’ argument. In this way, the briefing schedule already established for this case can be honored, and at the same ime, the goals of avoiding duplication of argument can also be achieved. "


So it appears the Group will be coming in from a different angle then the FDA from this filing on the Docket today.


Sun ​

 

[Sun Vaporer]

Today the Order came down against the FDA. I still have to read, the Ruling which is 32 pages long

 

[Sun Vaporer]

Here is the ruling:

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54


and here is the actual order:

http://www.casaa.org/files/SE-vs-FDA-Ruling.pdf

Sun